MENLO PARK, Calif., Feb. 15, 2024 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today reported its results for the quarter and year ended December 31, 2023. Financial Results Fourth quarter revenue of $135.4 million, a 31 percent increase over the same period in 2022Full year ...

MENLO PARK, Calif., Feb. 15, 2024 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today announced preliminary results from the prevalence phase of its ongoing CATALYST study of Cushing's syndrome (hypercortisolism) in patients with difficult-to-control type 2 diabetes. With a pl ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 000-50679 (Exact Name of Corporation as Specified in Its Charter) Delaware 77-0487658 (State or other jurisdiction of incorporation or organization ...

Have you been searching for a stock that might be well-positioned to maintain its earnings-beat streak in its upcoming report? It is worth considering Corcept Therapeutics (CORT) , which belongs to the Zacks Medical - Drugs industry.When looking at the last two reports, this drug developer has recorded a strong streak of surpassing earnings estimates. The company has topped estimates by 46.97%, on average, in the last two quarters.For the last reported quarter, Corcept came out with earnings of $0.28 per sh ...

MENLO PARK, Calif., Jan. 29, 2024 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today announced the appointment of Roberto Vieira as President, Oncology. He will report to Joseph K. Belanoff, MD, Corcept's Chief Executive Officer, and join the company's Executive Team. Mr. Vie ...

Financial Data and Key Metrics Changes - The company's revenue for Q3 2023 was $123.6 million, representing a 22% increase compared to the same quarter last year [47] - Net income for the quarter was $31.4 million, or $0.28 per share [47] - Cash and investments as of September 30th totaled $414.8 million, an increase of $51.5 million during the quarter [47] - The revenue guidance for 2023 has been raised to a range of $470 million to $480 million, up from the previous range of $455 million to $470 million [52] Business Line Data and Key Metrics Changes - The growth in revenue was driven by a 12% increase in volume and a 9% increase in price for Korlym [79] - The company is experiencing a mix of new prescribers and repeat prescriptions from existing physicians, contributing to the growth in Korlym sales [82] Market Data and Key Metrics Changes - There is an increasing recognition among physicians that hypercortisolism is more common than previously assumed, leading to more screenings and diagnoses [80] - The CATALYST study is expected to provide further evidence supporting the prevalence of hypercortisolism, which could enhance the treatment landscape for Cushing's syndrome [51] Company Strategy and Development Direction - The company is focused on expanding its sales force and improving the effectiveness of its team, with a target of increasing the sales force from mid-60s to about 75 [18] - The company is advancing multiple clinical development programs, including GRACE, GRADIENT, CATALYST, ROSELLA, and DAZALS studies, with significant milestones expected in 2024 [35][43] - The company is optimistic about the growth potential of its Cushing's syndrome business and the broader applications of cortisol modulation in various diseases [73] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strength of their case against Teva Pharmaceuticals regarding patent infringement, which is expected to be resolved by mid-2025 [32] - The management anticipates continued growth in the Cushing's syndrome market as more physicians become aware of the condition and its treatment options [51] Other Important Information - The company has robust intellectual property protections for both Korlym and relacorilant, with protections extending through 2037 and beyond 2040, respectively [25][26] - The company introduced a new executive team member, Monica Toledo, who will focus on emerging markets such as ALS and NASH [74] Q&A Session Summary Question: Can you provide specifics on the year-over-year volume growth for Korlym? - The company reported a 22% growth, with 12% driven by volume and 9% by price [79] Question: What does the increase in screening for hypercortisolism mean for future growth? - The recognition that hypercortisolism is more common is expected to sustain growth as more patients are diagnosed and treated [80] Question: Can you elaborate on the GRACE study and its primary endpoint? - The GRACE trial is evaluating dosing escalation and aims to show significant improvement in patients with Cushing's syndrome [85]

Cushing's Syndrome Treatments - Korlym is marketed in the United States for treating Cushing's syndrome, with a focus on patient access through specialty pharmacy and distributor support, alongside patient assistance programs[96] - Relacorilant, a selective cortisol modulator, is in Phase 3 trials (GRACE and GRADIENT) for Cushing's syndrome, with 152 patients enrolled in GRACE and 130 planned for GRADIENT[97][98][99] - The GRADIENT trial aims to study relacorilant's effects on glucose metabolism and hypertension in patients with benign adrenal tumors, with half receiving the drug and half receiving placebo for 22 weeks[99] - Relacorilant has been designated as an orphan drug by the FDA and EC, offering tax credits, reduced fees, and exclusive marketing rights for 7 years in the U.S. and 10 years in the EU[114] - The CATALYST Phase 4 study aims to evaluate the prevalence of Cushing's syndrome in up to 1,000 patients with difficult-to-control diabetes, with potential randomization to Korlym or placebo for 24 weeks[111] Financial Performance and Expenses - Stock-based compensation expense for 2023 totaled $12.9 million for the three months and $36.0 million for the nine months, compared to $10.6 million and $32.1 million in 2022, respectively[103] - Income tax expense for the three and nine months ended September 30, 2023, was $5.0 million and $13.0 million, respectively, compared to a benefit of $1.6 million and expense of $7.1 million in 2022[106] - Research and development expenses for the three and nine months ended September 30, 2023, were $4.0 million and $11.2 million, respectively, compared to $3.1 million and $9.7 million in 2022[103] Stock Options and Compensation - As of September 30, 2023, the company had 23.3 million stock options, 0.1 million RSUs, and 0.7 million RSAs outstanding, compared to 23.5 million, 0.2 million, and 0.2 million in 2022[105] Tax and R&D Regulations - The Tax Cuts and Jobs Act of 2017 requires U.S. and foreign R&D expenditures to be amortized over five and fifteen years, respectively, with no modifications as of September 30, 2023[108]

Financial Data and Key Metrics Changes - Revenue for the second quarter of 2023 was $117.7 million, a 14% increase compared to the same period last year [8] - Net income was $27.5 million or $0.25 per share, compared to $27.4 million or $0.24 per share in the same period last year [8] - Cash and investments totaled $363.3 million as of June 30, reflecting the purchase of 6.6 million shares for $145.4 million during the quarter [8] - The company raised its 2023 revenue guidance to a range of $455 million to $470 million, up from $435 million to $455 million [8] Business Line Data and Key Metrics Changes - The Cushing's Syndrome business is experiencing growth, with more patients receiving Korlym and an increase in the number of prescribing physicians [120] - The CATALYST study is expected to provide further evidence of the prevalence of hypercortisolism in patients with type 2 diabetes, which may lead to increased treatment rates [122] Market Data and Key Metrics Changes - The prevalence of hypercortisolism in patients with type 2 diabetes is estimated to be significantly higher than in the general population, with studies indicating rates of 10% to 20% [129] - The updated European Society of Endocrinology guidelines encourage physicians to look harder for hypercortisolism, which is expected to increase screening and diagnosis [131] Company Strategy and Development Direction - The company is focused on cortisol modulation as a therapeutic mechanism for various serious disorders, with proprietary compounds being developed for conditions like Cushing's Syndrome, NASH, and various cancers [124] - The company plans to submit an NDA for relacorilant in Cushing's Syndrome in the second quarter of 2024 and is advancing multiple clinical trials [10][12][124] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth potential of the Cushing's Syndrome business and the impact of ongoing clinical development programs [22][124] - The company anticipates continued growth in revenue and patient treatment rates, driven by increased disease awareness and improved field execution [126] Other Important Information - The CATALYST study is a landmark study evaluating the prevalence of hypercortisolism in difficult-to-treat type 2 diabetes patients, with enrollment expected to complete ahead of schedule [122][129] - The company is also conducting a Phase 1b trial of miricorilant for NASH, with promising results from previous studies [11][124] Q&A Session Summary Question: What drove the revenues in the second quarter and confidence in increasing guidance? - Management attributed revenue growth to improved access and field execution, with more patients and prescribers for Korlym [126] Question: What are the implications of the updated European Society of Endocrinology guidelines? - The guidelines encourage increased screening for hypercortisolism, which is expected to enhance diagnosis and treatment rates [131] Question: What are the dynamics of miricorilant in terms of efficacy and safety? - Management highlighted the rapid reduction in liver fat and improvements in liver enzymes observed in previous studies, supporting the advancement to Phase IIb [88]

[PART I. FINANCIAL INFORMATION](index=4&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Financial Statements](index=4&type=section&id=ITEM%201.%20FINANCIAL%20STATEMENTS) Corcept Therapeutics reported net product revenue of $117.7 million for Q2 2023, a 14% increase year-over-year, and $223.4 million for the first six months of 2023, with net income for the quarter at $27.5 million and a strong financial position of $363.3 million in cash, cash equivalents, and marketable securities [Condensed Consolidated Statements of Income](index=5&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20INCOME) For the three months ended June 30, 2023, net product revenue increased to $117.7 million, but income from operations decreased to $29.6 million due to higher operating expenses, while net income remained relatively flat at $27.5 million Condensed Consolidated Statements of Income (Three Months Ended June 30) | Metric | 2023 (in thousands) | 2022 (in thousands) | Change | | :--- | :--- | :--- | :--- | | Product revenue, net | $117,715 | $103,386 | +13.9% | | Total operating expenses | $88,132 | $71,954 | +22.5% | | Income from operations | $29,583 | $31,432 | -5.9% | | Net income | $27,528 | $27,412 | +0.4% | | Diluted net income per common share | $0.25 | $0.24 | +4.2% | Condensed Consolidated Statements of Income (Six Months Ended June 30) | Metric | 2023 (in thousands) | 2022 (in thousands) | Change | | :--- | :--- | :--- | :--- | | Product revenue, net | $223,369 | $197,074 | +13.3% | | Total operating expenses | $178,933 | $138,873 | +28.8% | | Income from operations | $44,436 | $58,201 | -23.6% | | Net income | $43,407 | $50,209 | -13.5% | | Diluted net income per common share | $0.38 | $0.44 | -13.6% | [Condensed Consolidated Balance Sheets](index=4&type=section&id=CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS) As of June 30, 2023, total assets decreased to $524.6 million from $583.4 million at year-end 2022, primarily due to reduced marketable securities and increased treasury stock, while total liabilities rose to $103.0 million and stockholders' equity declined to $421.6 million Key Balance Sheet Items (in thousands) | Account | June 30, 2023 | December 31, 2022 | | :--- | :--- | :--- | | Cash and cash equivalents | $172,377 | $66,329 | | Total current assets | $432,588 | $499,253 | | Total assets | $524,625 | $583,430 | | Total liabilities | $103,011 | $81,588 | | Total stockholders' equity | $421,614 | $501,842 | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20CASH%20FLOWS) For the six months ended June 30, 2023, net cash from operating activities increased to $68.2 million, investing activities provided $183.4 million due to a shift from marketable securities, and financing activities used $145.6 million primarily for common stock repurchases Cash Flow Summary (Six Months Ended June 30, in thousands) | Cash Flow Activity | 2023 | 2022 | | :--- | :--- | :--- | | Net cash provided by operating activities | $68,243 | $53,287 | | Net cash provided by (used in) investing activities | $183,378 | $(92,296) | | Net cash used in financing activities | $(145,573) | $(3,262) | | **Net increase (decrease) in cash** | **$106,048** | **$(42,271)** | - The company repurchased common stock for **$145.4 million** in connection with a Tender Offer during the first six months of 2023[32](index=32&type=chunk) [Notes to Condensed Financial Statements](index=9&type=section&id=NOTES%20TO%20CONDENSED%20FINANCIAL%20STATEMENTS) The notes detail key accounting policies and events, including a **$14.0 million** Melucci litigation settlement fully covered by insurance, a March 2023 tender offer repurchasing **6.6 million shares** for **$145.4 million**, and **$23.1 million** in stock-based compensation expense for the first six months of 2023 - The company reached an agreement in principle to settle the Melucci litigation for a one-time payment of **$14.0 million**, which will be fully covered by insurers[45](index=45&type=chunk) - In March 2023, the company commenced a tender offer and subsequently purchased **6.6 million shares** of its common stock for an aggregate price of **$145.4 million**[49](index=49&type=chunk) Stock-Based Compensation Expense (in thousands) | Period | 2023 | 2022 | | :--- | :--- | :--- | | Three Months Ended June 30 | $11,892 | $10,662 | | Six Months Ended June 30 | $23,125 | $21,487 | [Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A)](index=17&type=section&id=ITEM%202.%20MANAGEMENT'S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) Management attributes the **14% year-over-year revenue growth** in Q2 2023 to higher sales volumes and a price increase, while advancing its clinical pipeline with multiple Phase 3 and Phase 2 trials, expecting higher R&D expenses in 2023, and confirming sufficient capital for at least the next 12 months - The company is a commercial-stage pharmaceutical firm focused on modulating the hormone cortisol to treat severe disorders, with its main product being Korlym®, approved for Cushing's syndrome[35](index=35&type=chunk)[87](index=87&type=chunk) - Key clinical development programs include: - **Relacorilant:** Two Phase 3 trials (GRACE and GRADIENT) for Cushing's syndrome and a pivotal Phase 3 trial (ROSELLA) for ovarian cancer - **Dazucorilant:** A Phase 2 trial (DAZALS) for Amyotrophic Lateral Sclerosis (ALS) - **Miricorilant:** A planned Phase 2b trial for Nonalcoholic steatohepatitis (NASH) and a planned Phase 1 trial for preventing antipsychotic-induced weight gain[89](index=89&type=chunk)[120](index=120&type=chunk)[123](index=123&type=chunk) Results of Operations Highlights (Three Months Ended June 30) | Metric (in millions) | 2023 | 2022 | Change | | :--- | :--- | :--- | :--- | | Net product revenue | $117.7 | $103.4 | +13.8% | | Research and development | $43.3 | $32.8 | +32.0% | | Selling, general and administrative | $43.3 | $37.8 | +14.6% | - The company expects to fund its operations and planned R&D activities for the next 12 months and beyond without needing to raise additional funds, based on current plans and expectations[199](index=199&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=22&type=section&id=ITEM%203.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISK) The company states that its market risks as of June 30, 2023, primarily associated with cash, cash equivalents, and marketable securities, have not materially changed from those disclosed in its 2022 Annual Report on Form 10-K - There were no material changes in the company's market risks during the six months ended June 30, 2023[243](index=243&type=chunk) [Controls and Procedures](index=22&type=section&id=ITEM%204.%20CONTROLS%20AND%20PROCEDURES) Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of June 30, 2023, with no material changes to internal control over financial reporting identified during the quarter - The CEO and CFO concluded that as of June 30, 2023, the company's disclosure controls and procedures were effective[203](index=203&type=chunk) - No material changes to internal control over financial reporting were identified during the quarter ended June 30, 2023[244](index=244&type=chunk) [PART II. OTHER INFORMATION](index=23&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=23&type=section&id=ITEM%201.%20LEGAL%20PROCEEDINGS) The company is involved in ongoing patent infringement litigation with Teva Pharmaceuticals regarding a generic Korlym, settled a similar suit with Hikma, reached an agreement to settle the Melucci securities class action for **$14.0 million** fully covered by insurance, and is cooperating with a subpoena from the U.S. Attorney's Office - The company is in ongoing patent litigation with Teva Pharmaceuticals over its ANDA for a generic version of Korlym, with a trial scheduled for September 27, 2023[245](index=245&type=chunk)[184](index=184&type=chunk) - Litigation with Hikma Pharmaceuticals was resolved via a settlement agreement in December 2022, granting Hikma the right to sell a generic version of Korlym beginning October 1, 2034, or earlier under certain circumstances[188](index=188&type=chunk) - The Melucci securities class action lawsuit has been resolved in principle with a proposed settlement of **$14.0 million**, which will be paid in full by the company's insurers[141](index=141&type=chunk) - The company received a subpoena from the U.S. Attorney's Office for the District of New Jersey in November 2021 seeking information on the sale and promotion of Korlym and is cooperating with the investigation[191](index=191&type=chunk)[261](index=261&type=chunk) [Risk Factors](index=24&type=page&id=ITEM%201A.%20RISK%20FACTORS) The company identifies several key risks, including high dependence on Korlym revenue and threats from generic competition and the Inflation Reduction Act, inherent uncertainties in clinical trials, intellectual property protection, reliance on third-party manufacturers, and potential stock price volatility - **Commercial Risk:** The company's financial results are highly dependent on the sale of Korlym, and the successful commercialization of a generic version would adversely affect business[149](index=149&type=chunk)[170](index=170&type=chunk) - **Regulatory and Pricing Risk:** The Inflation Reduction Act of 2022 (IRA) is expected to significantly limit revenue from Medicare patients through inflation rebates and future price negotiations, potentially reducing profits[153](index=153&type=chunk)[157](index=157&type=chunk)[159](index=159&type=chunk) - **Competition Risk:** Other approved medications for Cushing's syndrome, such as Isturisa® and Recorlev®, compete with Korlym and could reduce its market share[139](index=139&type=chunk)[152](index=152&type=chunk) - **Development Risk:** The company's efforts to develop and commercialize new product candidates are lengthy, expensive, and may not succeed, as failure can occur at any stage of clinical development[174](index=174&type=chunk)[261](index=261&type=chunk) - **Supply Chain Risk:** The company relies on a single third-party manufacturer for Korlym's active pharmaceutical ingredient (API), and any disruption could harm the business[164](index=164&type=chunk)[165](index=165&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=38&type=section&id=ITEM%202.%20UNREGISTERED%20SALES%20OF%20EQUITY%20SECURITIES%20AND%20USE%20OF%20PROCEEDS) The company reported no unregistered sales of equity securities, but repurchased **6.6 million shares** for **$145.4 million** through a tender offer in April 2023, and acquired **202,040 shares** for approximately **$4.8 million** via cashless net exercises of stock options Issuer Purchases of Equity Securities (Tender Offer) | Period | Total Shares Purchased | Average Price Per Share | Total Cost (in thousands) | | :--- | :--- | :--- | :--- | | April 2023 | 6,610,000 | $22.00 | $145,428 | | May 2023 | 0 | N/A | $0 | | June 2023 | 0 | N/A | $0 | | **Total** | **6,610,000** | **$22.00** | **$145,428** | Issuer Purchases of Equity Securities (Cashless Exercises) | Period | Total Shares Purchased | Average Price Per Share | Total Cost (in thousands) | | :--- | :--- | :--- | :--- | | April 2023 | 13,461 | $22.58 | $304 | | May 2023 | 166,673 | $24.03 | $4,005 | | June 2023 | 21,906 | $23.44 | $514 | | **Total** | **202,040** | **$23.87** | **$4,823** |

Call Start: 17:00 January 1, 0000 5:41 PM ET Corcept Therapeutics Incorporated (NASDAQ:CORT) Q1 2023 Earnings Conference Call May 3, 2023 17:00 ET Company Participants Atabak Mokari - Chief Financial Officer Charlie Robb - Chief Business Officer Joseph Belanoff - Chief Executive Officer Bill Guyer - Chief Development Officer Conference Call Participants Matt Kaplan - Ladenburg Thalmann David Amsellem - Piper Sandler Edward Nash - Canaccord Genuity Roanna Ruiz - SVB Securities Greg Fraser - Truist Operator G ...